Before submitting an application to conduct research with human participants, ALL of the researchers and research assistants who will be involved with the project (e.g., principal investigators, faculty, student researchers) must complete one of the following courses:

• the free Good Clinical Practice eCourse created by the National Institutes of Health (NIH) Office of Behavioral and Social Sciences Research (OBSSR) and hosted by the Society of Behavioral Medicine (SBM), OR
• the Social-Behavioral-Educational Basic Course in Human Subjects Research offered by the Collaborative Institutional Training Initiative (CITI)

Each researcher’s certificate of completion must be dated within the past 3 years and must be submitted to FXUA’s IRB in PDF form as part of the application, along with the record/tracking number.

Additional information on accessing these courses is provided below.

To take the Good Clinical Practice (GCP) eCourse, you will first need to create a free account with the Society of Behavioral Medicine as a non-member/extramural researcher: https://sbm.execinc.com/edibo/Account

This will allow you to earn a certificate which you can then submit to the IRB as part of your application. The GCP course can be accessed at the following address: https://www.sbm.org/training/good-clinical-practice-for-social-and-behavioral-research-elearning-course

As explained on the OBSSR website, “Investigators… who are competent in GCP principles will be better able to assure that the rights, safety, and well-being of human subjects are protected; that clinical trials are conducted in accordance with approved plans and with rigor and integrity; and that data derived from clinical trials are reliable” (Office of Behavioral and Social Sciences Research, n.d., para 2).

The training contains 9 video modules with a variety of interactive quizzes and knowledge tests. You must work through the modules in order. If you have problems with the functionality of the training website, please email . If you have questions about the content of the training, please contact or .

Fairfax University of America does not have institutional access to the CITI Social-Behavioral-Educational (SBE) Basic Course. However, if you have access to this training through another organization, FXUA’s IRB will recognize your completion of those modules as meeting our training requirement.

Information about the CITI SBE course is available at the following address: https://about.citiprogram.org/en/course/human-subjects-research-2. The login page is available here: https://www.citiprogram.org/login. If needed, instructions are available in a “getting started” video and written guide.

References

CITI Program. (n.d.). Social-Behavioral-Educational (SBE) Basic. Available from https://about.citiprogram.org/en/course/human-subjects-research-2/

Office of Behavioral and Social Sciences Research. (n.d.). Online training resources. National Institutes of Health. Available from https://obssr.od.nih.gov/training/online-training-resources/

Society of Behavioral Medicine. (2020). Good Clinical Practice eCourse. Available from https://www.sbm.org/training/good-clinical-practice-for-social-and-behavioral-research-elearning-course

Helpful Videos

Anderson, M. A. (2016). Back to basics: Does my project fall within the scope of the regulations? [Webinar Video]. U.S. Department of Health and Human Services. Available from https://www.hhs.gov/ohrp/education-and-outreach/online-education/videos/all-videos/index.html and https://youtu.be/o2fZs_XOMTs

 [NOTE: Investigators themselves cannot make a determination as to whether their research can be considered exempt from IRB review. The IRB itself makes that determination.]

Feige, M. (2012). When PI’s come a-knockin: Everything investigators want to know but are afraid to ask. [Webinar Video]. U.S. Department of Health and Human Services. Available from https://www.hhs.gov/ohrp/education-and-outreach/online-education/videos/all-videos/index.html and https://youtu.be/FLoHNTuifGQ

Hernandez, J. O. (2016). What you should know about IRB review of research. [Webinar Video]. U.S. Department of Health and Human Services. Available from https://www.hhs.gov/ohrp/education-and-outreach/online-education/videos/all-videos/index.html and https://youtu.be/_UK5QatUEKE

Additional Resources

Department of Health, Education, and Welfare. (1979). The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Available from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

Office of Behavioral and Social Sciences Research. (2010). eSource: Introductory social and behavioral science training material. National Institutes of Health. Available from https://obssr.od.nih.gov/training/online-training-resources/esource/

Prior to beginning any research that involves human participants, you must apply for and obtain IRB approval.

Please note that since the IRB must approve your proposed recruitment procedures as well as your proposed methods of minimizing risks, protecting participants’ confidentiality, ensuring their autonomy, and so on, this means that you must obtain IRB approval before you begin seeking participants for your study. You may not begin recruiting or conducting the research until you have obtained official written approval from the IRB.

Also note that it is the IRB that determines the type of review required for any proposed research with human participants. The researchers themselves cannot determine whether their study meets the criteria for exempt status.

The IRB Chair conducts initial reviews of applications on a rolling basis. Applications meeting the criteria for exemption or expedited review are delegated immediately to individual members of the IRB. Those requiring a full review must be reviewed and discussed by all IRB members as a group.

As needed, the full IRB meets on the second Monday of each month to review applications and other documentation. Applications to conduct research with human participants must be submitted at least two (2) weeks prior to each meeting in order to be considered in a timely manner.

In order to obtain IRB approval to conduct research with human participants, follow the procedures below:

1. If you are a student, contact and secure a faculty advisor. If you are conducting research for a class, the course instructor will serve as your faculty advisor.
2. All researchers involved in a proposed study must complete a set of Required IRB Training modules on the protection of human research participants.
3. Once you have completed the training, fill out the Application for Research with Human Participants, which is available on the Forms & Documents
4. Submit your completed application along with documentation of your completion of the training requirement and all of your research materials (e.g., recruitment materials, informed consent form, grant proposal, letters of cooperation, research instruments) to  at least 2 weeks prior to the next IRB meeting.
5. Wait for official written approval from the IRB before you begin any recruitment or data collection for your research. This is very important!
6. Upon receiving a decision of approval from the IRB in writing, you may begin recruiting participants and conducting your research. (If you are a student, this will be under the supervision of your faculty advisor.)
7. If your research protocol must be changed for any reason, you will need to submit a Change in Protocol Form.
8. If any adverse events arise, you must submit an Adverse Events Form immediately upon discovering or encountering an adverse event.
9. If your research will exceed 12 months in duration, you must submit an Annual Review Form prior to the end of the 11th month of your research.

• Application to Conduct Research with Human Participants
• Consent Form Checklist and Template(for adults)
• Assent Form Template(for minors)
• Annual Review Form
• Adverse Events Form
• Change in Protocol Form